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9835
PERM

Compliance Engineer

Location: Waltham, Massachusetts

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:

 

Date Posted: 4/15/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Compliance Engineer

Industry: Medical

Location: Waltham, MA 02454     

Employment Type: Full Time, Permanent

Pay Range: 90-115K

Duration: Permanent

Job#: bh9835

 

Compliance Engineer  

Overview:

As a Compliance Engineer, this individual will serve as a key member of the development engineering department focused on new product development. The position will be responsible performing DFMEA on new designs as well as ensuring products are designed to meet all regulatory and compliance requirements

General Responsibilities:

  • Review proposed designs to ensure they will comply with Medical device standards. Work closely with system architect and other team members during new product development process
  • DFMEA analysis completed and controls implemented to ensure products are designed with a focus on   safety and reliability
  • Knowledgeable in applying WCCA, MTBF, HASS and HALT and other reliability assessment methods to electronic components and assemblies.  
  • Interface with Regulatory Department to ensure products are designed to meet country specific safety standards
  • Shepard new products through IEC60601 approval process including 2nd, 3rd and 4th editions as necessary. Provide hands on support working with off-site test agencies to obtain regulatory approval.
  • Familiar with testing products for EMC compliance and single fault conditions
  • Proficient in Microsoft Office, Excel, and Word
  • Hazard and Risk Analysis documentation
  • Other Regulatory/Compliance documentation or activities as needed
  • Ensure that all products/processes to be developed comply with FDA, and other regulatory standards/guidelines as well as company SOPs.

Knowledge/Educational Requirements

  • 8+ years of directly related experience in a regulated industry.
  • Bachelor of Science Electrical Engineering preferred
  • Intimate familiarity with IEC 60601 Compliance for Medical Devices
  • Experience performing DFMEA on complex medical devices

Experience with laser devices a plus

 

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

                 

Contact Info:                                                                                                                                       

 

ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776

jobpostings@csetalent.com